United States Notification: USA/176

1. Date issued: 2/17/2006

2. Agency Responsible: Food and Drug Administration (FDA)
3. National Inquiry Point: National Center for Standards and Certification Information, National Institute of Standards and Technology (NCSCI/NIST)

4. Notified under Article: 2.9.2

5. Products covered: Medical Devices (HS 9018)

6. ICS Codes: 11.040

7. Title: Medical Devices; Radiology Devices; Reclassification of Bone Sonometers

8. Description of content: The Food and Drug Administration (FDA) is publishing a proposed rule to reclassify bone sonometer devices from class III into class II, subject to special controls. A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance document entitled "Class II Special Controls Guidance Document: Bone Sonometers" that the agency proposes to use as a special control for these devices.

9. Objective and rationale: Protection of human health

10. Relevant documents: 71 Federal Register (FR) 7894 15 February 2006; Title 21 Code of Federal Regulations (CFR) Part 892. Will appear in the Federal Register when adopted.

11. Proposed date of adoption: Not given by country

12. Proposed date of entry into force: Not given by country

13. Final date for comments: 5/16/2006

14. Full text URL: http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/E6-2076.htm

15. Full text URL 2: http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/E6-2076.pdf

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